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Application of Economics & Social Psychology to Improve Opioid Prescribing Safety (AESOPS): R21 Pilot Phase (AESOPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03773484
Recruitment Status : Enrolling by invitation
First Posted : December 12, 2018
Last Update Posted : April 4, 2019
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Northwestern University
RAND
Sutter Health
Asante Health System
AltaMed Health Services
The Children's Clinic
Information provided by (Responsible Party):
Jason Doctor, University of Southern California

Tracking Information
First Submitted Date  ICMJE December 10, 2018
First Posted Date  ICMJE December 12, 2018
Last Update Posted Date April 4, 2019
Actual Study Start Date  ICMJE March 25, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
Changes in daily milligram morphine equivalent [ Time Frame: 6 months ]
We will estimate daily milligram morphine equivalent for each clinician and observe the change each month. This will capture CDC guideline prescribing endpoints.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
Rate of dose escalation [ Time Frame: 6 months ]
Evaluate the transition from low to high dose prescribing
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Application of Economics & Social Psychology to Improve Opioid Prescribing Safety (AESOPS): R21 Pilot Phase
Official Title  ICMJE Application of Economics & Social Psychology to Improve Opioid Prescribing Safety (AESOPS): R21 Pilot Phase
Brief Summary There is a lack of evidence that long-term opioid use offers benefit for noncancer pain and an abundance of evidence of harm. The objective of the R21 pilot phase of the Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS) is to develop and test novel behavioral nudges to encourage adherence to pain and CDC guidelines for opioid prescribing for persons with noncancer pain. Interventions will leverage the electronic health record (EHR): Accountable Justification alerts triggered by discordant prescriptions that populate the note with provider's rationale for guideline exceptions and Active Choice (SmartSet) that are triggered by EHR workflow containing exclusively guideline concordant choices. Clinicians will also receive audit and feedback on their performance during the prior quarter as well as in comparison to other clinicians on CDC quality measures.
Detailed Description There is a lack of evidence that long-term opioid use offers benefit for noncancer pain and an abundance of evidence of harm. In 2017, the Centers for Disease Control and Prevention (CDC) issued the "CDC Guideline for Prescribing Opioids for Chronic Pain" to encourage safe and effective alternatives to opioids, discontinuation of opioids when patients do not resume normal activities and prudent dosing strategies. However, poor guideline adherence is a general concern and may impede uptake. Our prior studies have used insights from behavioral economics and social psychology to increase guideline adherence. The objective of the R21 pilot phase of the Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS) is to develop and test the following novel behavioral nudges to encourage adherence to pain and CDC guidelines for opioid prescribing for persons with noncancer pain: 1) Accountable Justification alert will have clinicians enter a brief statement justifying their opioid prescription for new orders or refills. The note will then be added to the patient's medical record, 2) The Active Choice (SmartSet) alert will encourage clinicians to engage in a taper discussion with the patient and either begin a taper or justify a reason for continuing medication, 3) Audit and Feedback will provide clinicians with aggregate data on their performance relative to top-performing peers on CDC measures of interest. This information will be reported back to the clinician by mail, email or within the electronic health record. Peer comparison encourages clinician to follow the lead of top performers, as we often follow the lead of others similar to ourselves.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Opioid Use, Unspecified
Intervention  ICMJE
  • Behavioral: Accountable Justification
    Accountable Justification is triggered by discordant prescriptions that populate the EHR note with provider's rationale for guideline exceptions.
  • Behavioral: Active Choice (SmartSet)
    Active Choice (SmartSet) will be triggered within the EHR for patients with long-term opioid to encourage taper discussion, increase use of nonopioid alternatives, naloxone prescriptions and urine drug testing
  • Behavioral: Audit and Feedback
    Clinicians will receive feedback on their performance during the prior quarter as well as how they compare to other clinicians on CDC measures of interest.
Study Arms  ICMJE Experimental: Clinical Decision Support/Audit & Feedback
Clinical decision support nudges (Accountable Justification and Active Choice (SmartSet)) within the electronic health record and Audit and Feedback on performance. Participating clinicians will receive any of three nudges when eligibility criteria are met within a patient's chart.
Interventions:
  • Behavioral: Accountable Justification
  • Behavioral: Active Choice (SmartSet)
  • Behavioral: Audit and Feedback
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: December 10, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • NM clinic that sees patients ≥ 18 years old whose leadership agrees to participate

Exclusion Criteria:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03773484
Other Study ID Numbers  ICMJE HS-CG-17-00019
R21AG057395-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jason Doctor, University of Southern California
Study Sponsor  ICMJE University of Southern California
Collaborators  ICMJE
  • National Institute on Aging (NIA)
  • Northwestern University
  • RAND
  • Sutter Health
  • Asante Health System
  • AltaMed Health Services
  • The Children's Clinic
Investigators  ICMJE
Principal Investigator: Jason N Doctor, PhD University of Southern California
PRS Account University of Southern California
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP